Person and Covey
Form 483 issued January 30, 2020 · Glendale, California
- Inspection
- Jan 28 – Jan 30, 2020
- Investigator
- Bryan L. McGuckin
- Observations
- 6
- Pages
- 5
- FEI number
- 2011222
In short: On January 30, 2020, FDA issued a Form 483 with 6 observations to Person and Covey in Glendale, California (FEI 2011222) after an inspection that ran Jan 28 – Jan 30, 2020. The investigator was Bryan L. McGuckin. Most observations concern production and materials.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
- 03
Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmPerson and Covey history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Person and Covey?
FDA listed 6 observations on this Form 483, mostly about production, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Person and Covey?
Bryan L. McGuckin is named on this Form 483, for the inspection of Jan 28 – Jan 30, 2020. Each investigator has a profile showing what they cite most.
When was Person and Covey inspected by FDA?
The inspection ran Jan 28 – Jan 30, 2020, and the Form 483 is dated January 30, 2020.
How do I get the full Form 483 for Person and Covey?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.